ADR that result in revision of patient information
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| Australia: Methylphenidate: Use in pregnancy |
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Therapeutic Goods Administration (TGA) is advising health professionals that the Product Information (PI) documents for methylphenidate products have been updated with new information about use in pregnancy. The pregnancy category has now been changed from Category B3 to Category D and the PI documents include updated safety information relating to birth defects and malformations.
Methylphenidate is a central nervous system stimulant. Its mode of action in humans is not completely understood, but methylphenidate presumably exerts its stimulant effect by an inhibition of dopamine and norepinephrine reuptake into presynaptic neurons and thereby increasing these neurotransmitters in the extraneuronal space.
The pregnancy category for methylphenidate was changed from pregnancy Category B3 to Category D due to a small increased occurrence of foetal cardiac malformations in women who received methylphenidate during the first trimester of pregnancy, compared with non-exposed pregnancies seen in large observational studies.
As at 4 Jun 2021, no cases of foetal cardiac malformations associated with methylphenidate had been reported to the TGA. However, the World Health Organization's global individual case safety report database, VigiBase, has received 28 reports of this adverse event.
Health professionals are advised that methylphenidate should not be prescribed for women of childbearing age unless, in the opinion of the physician, the potential benefits outweigh the possible risks.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/methylphenidate-use-pregnancy
In Hong Kong, there are 26 registered pharmaceutical products containing methylphenidate. All products are prescription-only medicines. So far, the Department of Health (DH) has received one case of adverse drug reaction related to methylphenidate, but this case is not related to birth defects. In light of the above TGA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Jul 23, 2021
Issued at HKT 16:00
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